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Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

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ClinicalTrials.gov Identifier: NCT03691610
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE September 28, 2018
First Posted Date  ICMJE October 2, 2018
Last Update Posted Date March 20, 2020
Actual Study Start Date  ICMJE October 4, 2018
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
Antibody titers against meningococcal serogroups A, C, Y, and W [ Time Frame: 30 days after the second dose of meningococcal vaccine ]
Antibody titers are measured by serum bactericidal assay using human complement (hSBA)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W [ Time Frame: 30 days after the second dose of meningococcal vaccine ]
    % of participants achieving antibody titers ≥ predefined threshold of 1:8
  • Number of participants reporting solicited injection site reactions or systemic reactions [ Time Frame: Within 7 days after vaccination ]
    Injection site reactions: tenderness, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Official Title  ICMJE Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Brief Summary

The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.

The secondary objective is to demonstrate the non-inferiority of the percentage of subjects with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.

The study also includes as an observational objective to describe the safety profile of MenACYW conjugate vaccine and MENVEO® when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.

Detailed Description Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The study has a modified double blind design for each group at enrollment, and thus, with the exception of the personnel administering the vaccine, everyone involved in study is blinded to avoid any bias.
Primary Purpose: Prevention
Condition  ICMJE Healthy Volunteers (Meningococcal Infection)
Intervention  ICMJE
  • Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
    Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
  • Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
    Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
  • Biological: Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
    Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
  • Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
    Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
  • Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
  • Biological: Haemophilus b Conjugate Vaccine
    Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
  • Biological: Pneumococcal 13-valent Conjugate Vaccine
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
  • Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
    Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
  • Biological: Hepatitis B Vaccine
    Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
  • Biological: Measles, Mumps, and Rubella Virus Vaccine Live
    Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
  • Biological: Varicella Virus Vaccine Live
    Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
Study Arms  ICMJE
  • Experimental: Group 1
    MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
    Interventions:
    • Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
    • Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
    • Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
    • Biological: Haemophilus b Conjugate Vaccine
    • Biological: Pneumococcal 13-valent Conjugate Vaccine
    • Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
    • Biological: Hepatitis B Vaccine
    • Biological: Measles, Mumps, and Rubella Virus Vaccine Live
    • Biological: Varicella Virus Vaccine Live
  • Active Comparator: Group 2
    MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
    Interventions:
    • Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
    • Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
    • Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
    • Biological: Haemophilus b Conjugate Vaccine
    • Biological: Pneumococcal 13-valent Conjugate Vaccine
    • Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
    • Biological: Hepatitis B Vaccine
    • Biological: Measles, Mumps, and Rubella Virus Vaccine Live
    • Biological: Varicella Virus Vaccine Live
  • Experimental: Group 3
    MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age
    Intervention: Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
  • Active Comparator: Group 4
    Menactra® at 17 to 19 months of age and 20 to 23 months of age
    Intervention: Biological: Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2018)
940
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Aged 6 to 7 months (164 to 224 days) or 17 to 19 months on the day of the first visit
  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
  • Informed consent form has been signed and dated by the parent(s) or other guardian and by an independent witness if required by local regulations
  • Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
  • For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented history of having received 2 doses of diphtheria, tetanus and acellular pertussis (DTaP), Haemophilus influenza type B (Hib), inactivated poliovirus (IPV), pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and rotavirus vaccines
  • For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4), documented history of having received all routine pediatric vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) up to the age of enrollment

Exclusion criteria:

  • Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and / or following any trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
  • Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
  • For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), prior receipt of more than 2 doses of DTaP, Hib, IPV, pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of more than 3 doses of hepatitis B vaccine) or rotavirus vaccine
  • For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the rotavirus vaccine at 2 and 4 months of age
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months
  • Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated
  • Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
  • Individuals with active tuberculosis
  • History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease
  • At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
  • History of intussusception
  • History of any neurologic disorders, including any seizures and progressive neurologic disorders
  • History of Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
  • History of Guillain-Barré syndrome
  • Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast
  • Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the investigator's opinion
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator's opinion
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C [≥ 100.4 F]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  • Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 19 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03691610
Other Study ID Numbers  ICMJE MET61
U1111-1205-2836 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP